What is Zepbound, a new injectable for obesity – 11/10/2023 – Equilíbrio

Zepbound, the newest drug against obesity, was approved this week by the American regulatory agency FDA (Food and Drug Administration). Available in the form of an injectable pen, it is recommended for obese people with another associated condition. In Brazil, there is still no release date from Anvisa.

Tirzepatide was given the trade name Zepbound and showed results of up to 20% body weight loss in patients taking the highest dosages (15 mg). The studies carried out for approval involved 2,539 adults, who used the medicine for 72 weeks.

Manufactured by the American Eli Lilly, Zepbound is recommended for weekly use and has a monthly cost of US$1,059.87 (around R$5,000). It is launched at a time when its competitor, Wegovy (from Novo Nordisk), is successful, even missing from US shelves. In Brazil, despite being approved, Wegovy is expected to be commercialized in 2024.

The two pharmaceutical companies previously launched injections for type 2 diabetes: Ozempic (from Nordisk) and Mounjaro (from Eli Lilly). Both were released by Anvisa, but Mounjaro – approved in September – is not yet expected to be commercialized here. Despite the sole indication for diabetics, they ended up being used for weight loss, in off-label indications, that is, for problems not recommended in the leaflet.

The injections for obesity —Wegovy (semaglutide) and Zepbound (tirzepatide)— have the same active ingredients as the injections indicated for diabetes —Ozempic (semaglutide) and Mounjaro (tirzepatide)—, but with different dosages for each problem.

“Their profile is similar, but they are not the same. While semaglutide acts on one peptide, tirzepatide acts on two, acting to control satiety and appetite”, explains endocrinologist Cesar Boguszewski, professor at UFPR (Federal University of Paraná ).

He points out that treatment against obesity does not cause hypoglycemia in those who do not have diabetes, as the medicine will not lower it in those with blood glucose levels within the normal range. “We are not treating for weight loss, weight loss; we are treating a disease called obesity,” he says. “It is necessary to define the difference between what is a medical problem and an aesthetic problem.”

The endocrinologist highlights the evolution of science in discovering the entire pathophysiology of obesity, currently offering effective and very safe medications. The two biggest problems, points out the doctor, are the cost and the sale without the need for any medical prescription.

Who can use it?

People with a body mass index above 30 kg/m^twoor above 27 kg/m^two for those who have comorbidities and other weight-related conditions, such as hypertension, sleep apnea and heart disease. Medications should always be associated with a balanced diet and regular physical exercise.

How does tirzepatide work?

The medicine stimulates the production of two hormones: GLP-1, to stimulate insulin production and reduce blood sugar; and GIP, which enhances the effects of the previous one. In addition, these hormones have other effects, such as delaying stomach emptying and making the patient feel full faster and for longer, thus reducing the desire to eat and caloric intake.

What are the results?

During studies to approve the drug, obese people who took Zepbound for 72 weeks lost, on average, 18% of body weight in higher doses – for Wegovy the average is 15%.

What are the side effects?

Serious gastrointestinal problems may be observed, such as abdominal pain, reflux, diarrhea, constipation, nausea, vomiting, as well as dizziness, headache, hair loss, fatigue, hypersensitivity and skin rashes. Kidney failure, pancreatitis, depression, and suicidal thoughts have also been observed.

In what dosages will it be sold?

Zepbound (obesity) will have strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. Mounjaro (diabetes) in 5 mg, 10 mg, and 15 mg. The difference is the indication for treatment described in the leaflet.

What is the sale date and price?

In the USA it should be available in two months, for US$ 1,059.87 (around R$ 5,000.00). In Brazil, there is no forecast for sale, since, even though requested by the manufacturer, there has not yet been approval from Anvisa. Tirzepatide is also under regulatory review for obesity in Europe, China and the United Kingdom.

Do you have to take it for the rest of your life?

Yes, obesity is a chronic disease that can be controlled, but cannot be cured. When use is discontinued, weight regain almost always occurs.

Can anyone who already takes Ozempic or Wegovy change?

This assessment must be carried out by a doctor, who will observe the patient’s history and other associated conditions and treatments. It is worth remembering that each person reacts differently to medications, with results and side effects that need to be assessed in advance.